The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Test Pack Strep A Test.
| Device ID | K945571 |
| 510k Number | K945571 |
| Device Name: | ABBOTT TEST PACK STREP A TEST |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | ABBOTT LABORATORIES D-49C AP6C 200 ABBOTT PARK ROAD Abbott Park, IL 60064 -3537 |
| Contact | Mary Spiewak |
| Correspondent | Mary Spiewak ABBOTT LABORATORIES D-49C AP6C 200 ABBOTT PARK ROAD Abbott Park, IL 60064 -3537 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-07 |
| Decision Date | 1995-08-14 |